Status:
COMPLETED
Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
Lead Sponsor:
Pawel Kalinski
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Vaccines made from a person's dendritic cells mixed with tumor peptides and proteins may help the body build an effective immune response to kill tumor cells. Infusing the vaccine directly ...
Detailed Description
OBJECTIVES: Primary * Compare the safety of intralymphatic autologous type-1-polarized dendritic cell vaccine vs autologous mature dendritic cell vaccine loaded with antigenic peptides and proteins ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Pathologically confirmed stage III or IVA (M1a) melanoma
- Recurrent and inoperable disease
- Any tumor thickness and any number of lymph nodes involved
- Asymptomatic cutaneous and nodal disease allowed
- Asymptomatic pulmonary metastatic disease (stage IVB, M1b) allowed
- No advanced symptomatic visceral disease, including any symptomatic visceral organ involvement, or disease associated with increased serum lactic dehydrogenase \> 2.5 times upper limit of normal (stage IVC, M1c)
- Standard curative or palliative measures do not exist or are no longer effective
- Sufficient numbers of monocytes (≥ 20 x 10\^6) must be obtained for the preparation of the vaccine
- If an insufficient number of cells is obtained on first venipuncture, a second venipuncture may be performed (not exceeding 550 mL of blood within 8 weeks)
- No brain metastases by contrast-enhanced CT scan or MRI
- Prior brain metastases allowed provided they were successfully treated and patient has been asymptomatic for ≥ 3 months
- HLA-A2 positive
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy ≥ 6 months
- Granulocyte count ≥ 1,500/mm³
- Lymphocyte count ≥ 500/mm³
- Platelet count \> 70,000/mm³ (for venipuncture/pheresis procedure)
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN
- Gamma-glutamyl transferase ≤ 2.5 times ULN
- Lactic dehydrogenase ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- Bilirubin ≤ 1.5 times ULN
- No active infection
- No sensitivity to drugs that provide local anesthesia
- No pain uncontrolled by oral analgesics, including opiates and opiate analogs
- No active autoimmune disease
- No HIV, hepatitis B, or hepatitis C positivity
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Negative pregnancy test
- No other malignancy except for nonmelanoma skin cancers or carcinoma in situ of the cervix, or other malignancy for which the patient has been continuously disease-free for ≥ 2 years
- PRIOR CONCURRENT THERAPY:
- Recovered from prior surgery
- No radiotherapy, chemotherapy, or immunotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin C)
- No antibiotics within the past 7 days
- No systemic immunosuppressive agents, including steroids, within the past 4 weeks
- Concurrent maintenance steroids for adrenal insufficiency allowed
- No other concurrent anticancer investigational or commercial agents or therapies
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00390338
Start Date
October 1 2006
End Date
January 1 2015
Last Update
September 26 2017
Active Locations (2)
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1
UPMC Cancer Center at Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
2
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States, 15232